MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-07-01 for POSSIS 4320 manufactured by External Manufacturer.
[16560580]
Boston scientific received information that the patient received 28 inappropriate shocks due to noise and oversensing of the right ventricular (rv) lead and resulted in device therapy exhaustion. Boston scientific technical services (ts) was contacted and advised that the integrity of the lead system is in question. The leads were capped and replaced. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[16610548]
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2015-06455 |
| MDR Report Key | 4883139 |
| Report Source | 08 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-04-29 |
| Date of Event | 2015-04-24 |
| Date Mfgr Received | 2015-04-29 |
| Date Added to Maude | 2015-07-01 |
| 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 | 0 |
| Manufacturer Contact | SONALI VASEKAR |
| Manufacturer Street | 4100 HAMLINE AVE. N |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515824786 |
| Manufacturer G1 | EXTERNAL MANUFACTURER |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSSIS |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | NHW |
| Date Received | 2015-07-01 |
| Model Number | 4320 |
| ID Number | --- |
| Device Expiration Date | 1994-08-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXTERNAL MANUFACTURER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 41 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2015-07-01 |