MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-10-08 for UNKNOWN 4312 manufactured by Historical Cpi St. Paul.
[3036096]
Boston scientific received information that during a normal device changeout to a new device with a chronic epicardial lead, the setscrew of an attempted adapter became stuck, prohibiting the physician from pulling the terminal pin of the lead out of the adaptor. While manipulating the lead, physical damage was sustained, therefore the physician elected to cut and surgically abandon the remaining portion of the lead, removing the adapter with a portion of the lead still attached. No information could be obtained on precisely which of the two known chronic epicardial leads were involved in the event. The chronic device was successfully explanted and replaced on the other side of the patient's body with no header damage. The rest of the chronic leads were surgically abandoned electively as the implant site for the new system was on the left side. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[10327588]
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 | 2124215-2012-12243 |
| MDR Report Key | 2776081 |
| Report Source | 07 |
| Date Received | 2012-10-08 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-07-17 |
| Date Mfgr Received | 2012-07-17 |
| Date Added to Maude | 2012-10-08 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2012-10-08 |
| Model Number | 4312 |
| ID Number | --- |
| Device Expiration Date | 1994-04-04 |
| 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 | 439 | 2012-10-08 |