MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-10 for UNKNOWN 4312 manufactured by Historical Cpi St. Paul.
[3308263]
Boston scientific received information that this adaptor is part of an implanted system that exhibited a high out of range shock impedance measurement one day after implant. The new icd (model/serial f161/(b)(4)) was implanted with two epicardial tachycardia leads (model/serial 0041/(b)(4) and 0041/(b)(4)) with an adaptor for each (this adaptor and model/serial 4312/(b)(4)). The cause of the high shock impedance measurement was not unknown. A revision procedure was scheduled and the patient was hospitalized.
Patient Sequence No: 1, Text Type: D, B5
[10449842]
Additional information is expected with regard to this issue. This investigation will be updated should additional information become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2012-14581 |
| MDR Report Key | 2908374 |
| Report Source | 07 |
| Date Received | 2013-01-10 |
| Date of Report | 2012-10-18 |
| Date of Event | 2012-10-11 |
| Date Mfgr Received | 2012-10-18 |
| Date Added to Maude | 2013-01-10 |
| 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 | SHARON ZURN |
| Manufacturer Street | 4100 HAMLINE AVE. N |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515824786 |
| Manufacturer G1 | HISTORICAL CPI ST. PAUL |
| Manufacturer Street | GUIDANT CORPORATION |
| Manufacturer City | SAINT PAUL MN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | NHW |
| Date Received | 2013-01-10 |
| Model Number | 4312 |
| ID Number | --- |
| Device Expiration Date | 1992-06-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HISTORICAL CPI ST. PAUL |
| Manufacturer Address | GUIDANT CORPORATION SAINT PAUL MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 41 | 1. Hospitalization; 2. Required No Informationntervention | 2013-01-10 |