MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-02 for SWIFT-LOCK ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.
[181801014]
The event date is unknown. Concomitant medical products and therapy dates: model: 3186 (x2), scs leads, therapy date: unknown, model:#: 1192, scs anchor, therapy date: unknown. The patient's weight was unable to be obtained. The results/method and conclusion codes along with the investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[181801015]
Device 3 of 4; reference mfr. Report#: 3006705815-2020-01003, reference mfr. Report#: 3006705815-2020-01004, reference mfr. Report#: 1627487-2020-02353. It was reported one of the patient's leads had migrated and high impedance was present as a result. The patient later underwent surgical intervention and during the procedure the anchor associated with the lead that migrated was found to be broken. In turn, the physician decided to explant and replace both of the patient's leads and anchors to address the issue. Note: both of the patient's leads and anchors are being reported because it's unknown which devices were liable.
Patient Sequence No: 1, Text Type: D, B5
[188129894]
The reported event of breakage was confirmed on one of the return anchors. Both anchors passed functional testing. The cause of the breakage is consistent with overstress condition the anchor was subjected while in vivo.
Patient Sequence No: 1, Text Type: N, H10
[188129895]
Device 3 of 4: reference mfr. Report#: 3006705815-2020-01003. Reference mfr. Report#: 3006705815-2020-01004. Reference mfr. Report#: 1627487-2020-02353.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-02352 |
| MDR Report Key | 9777639 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2020-03-02 |
| 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 | ANDREA DEITZ |
| Manufacturer Street | 6901 PRESTON ROAD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098000 |
| Manufacturer G1 | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Street | 6901 PRESTON RD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWIFT-LOCK ANCHOR |
| Generic Name | SCS ANCHOR |
| Product Code | GZB |
| Date Received | 2020-03-02 |
| Model Number | 1192 |
| Catalog Number | 1192 |
| Lot Number | 6342722 |
| Device Expiration Date | 2020-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Address | 6901 PRESTON RD PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-02 |