MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-14 for NEO LEGACY 2100 100053-301 manufactured by Cvrx, Inc..
[47345238]
A pocket revision procedure was scheduled on monday, (b)(6) 2016 at 8am with dr. (b)(6) at the (b)(6) as the patient lives in (b)(6). The patient had a device replacement last (b)(6) in (b)(6) and it appears from x-ray that the device has moved in the pocket and the lead has become twisted since that time (possible twiddler's syndrome). The patient was unable to come in for an interrogation to assess the condition of the leads, so it was not clear if a repair would be needed in addition to the pocket revision. (b)(4) was present for the case. He brought lead repair kits a replacement ipg in case it was damaged, but they were not necessary. The procedure was completed by a fellow, not dr. (b)(6). Dr. (b)(6) attended though. The lead impedance was normal throughout. The leads were "balled" together, as seen on the x-ray, and scarred in. No attempt was made to dissect them out. A lead repair was not required. The leads were not removed from the ipg during the procedure. (b)(4) was not able to determine the status of the ipg before it was removed from the pocket, so was not sure if it was actually sutured in. He did not see any sutures cut from the ipg or removed from the pocket though. The surgeon used ethibond 0 to suture the device into the pocket, both ipg suture holes were used, the sutures were definitely placed into the fascia of the muscle. The device had to be rotated 180 degrees to fit back into the medial area of the pocket, so the leads are now facing lateral (towards the shoulder). (b)(4) agreed that this was appropriate for this situation.
Patient Sequence No: 1, Text Type: N, H10
[47345239]
Patient complained of pain and bruising on (b)(6) 2016 due to device moving out of the pocket. The last ipg replacement surgery took place on (b)(6) 2015 at (b)(6). Photos and x-rays sent on (b)(6) 2016 showed that the ipg had shifted in the pocket and the leds were intertwined but did not appear to be damaged.
Patient Sequence No: 1, Text Type: D, B5
[48588784]
A pocket revision procedure was scheduled on monday, (b)(6) 2016 at 8 am with dr. (b)(6) at (b)(6) as the patient lives in (b)(6). The patient had a device replacement last (b)(6) in (b)(6) and it appears from x-ray that the device has moved in the pocket and the lead has become twisted since that time (possible twiddler's syndrome). The patient was unable to come in for an interrogation to assess the condition of the leads so it was not clear if a repair would be needed in addition to the pocket revision. (b)(6) was present for the case. He brought lead repair kits a replacement ipg in case it was damaged, but they were not necessary. The procedure was completed by a fellow, not dr. (b)(6). Dr. (b)(6) attended though. The lead impedance was normal throughout. The leads were "balled" together, as seen on the x-ray, and scarred in. No attempt was made to dissect them out. A lead repair was not required. The leads were not removed from the ipg during the procedure. (b)(6) was not able to determine the status of the ipg before it was removed from the pocket, so was not sure if it was actually sutured in. He did not see any sutures cut from the ipg or removed from the pocket though. The surgeon used ethibond 0 to suture the device into the pocket, both ipg suture holes were used, the sutures were definitely placed into the fascia of the muscle. The device had to be rotated 180 degrees to fit back into the medial area of the pocket, so the leads are now facing lateral (towards the shoulder). (b)(6) agreed that this was appropriate for this situation. Follow-up report is submitted to correct initial report that stated this was 5 day reportable. This was incorrect. This was a 30 reportable event.
Patient Sequence No: 1, Text Type: N, H10
[48588785]
Patient complained of pain and bruising on (b)(6) 2016 due to device moving out of the pocket. The last ipg replacement surgery took place on (b)(6) 2015 at (b)(6). Photos and x-rays sent on (b)(6) 2016 showed that the ipg had shifted in the pocket and the leds were intertwined but did not appear to be damaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007972010-2016-00001 |
| MDR Report Key | 5723532 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-14 |
| Date of Report | 2016-06-10 |
| Date of Event | 2016-06-06 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2015-08-25 |
| Date Added to Maude | 2016-06-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. AL CROUSE |
| Manufacturer Street | 9201 WEST BROADWAY AVENUE SUITE 650 |
| Manufacturer City | MINNEAPOLIS MN 55445 |
| Manufacturer Country | US |
| Manufacturer Postal | 55445 |
| Manufacturer Phone | 7634167457 |
| Manufacturer G1 | CVRX, INC. |
| Manufacturer Street | 9201 WEST BROADWAY AVENUE SUITE 650 |
| Manufacturer City | MINNEAPOLIS MN 55445 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55445 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEO LEGACY |
| Generic Name | IMPLANTABLE PULSE GENERATOR |
| Product Code | DSR |
| Date Received | 2016-06-14 |
| Model Number | 2100 |
| Catalog Number | 100053-301 |
| Device Expiration Date | 2017-08-25 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CVRX, INC. |
| Manufacturer Address | 9201 WEST BROADWAY AVENUE SUITE 650 MINNEAPOLIS MN 55445 US 55445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-06-14 |