MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-11 for PATCH 0041 manufactured by Historical Puerto Rico.
[3370353]
Boston scientific received information that out of range shock impedances greater than 125 ohms were observed on the right ventricular (rv) lead. This was noted following the recent device change out that occurred in the previous month. This patient has an abdominal system. The concern was that this may be the cause of the out of range measurements. Boston scientific technical services (ts) discussed performing further testing or to perform a save to disc for further information. Subsequently additional information was received that four days following this report, this system was part of a revision due to an infection. No additional testing or follow-up was performed because of the infection. There were no patient symptoms or adverse effects related to the out of range impedance measurements. The leads were abandoned and remain implanted. The device will be returned.
Patient Sequence No: 1, Text Type: D, B5
[10390939]
The leads remain implanted and surgically abandoned. 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 | 2124215-2012-16480 |
| MDR Report Key | 2910803 |
| Report Source | 05 |
| Date Received | 2013-01-11 |
| Date of Report | 2012-11-16 |
| Date of Event | 2012-11-16 |
| Date Mfgr Received | 2012-11-16 |
| Date Added to Maude | 2013-01-11 |
| 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 PUERTO RICO |
| Manufacturer Street | GUIDANT PUERTO RICO B. V. |
| Manufacturer City | DORADO PR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATCH |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | NHW |
| Date Received | 2013-01-11 |
| Model Number | 0041 |
| ID Number | L 67 |
| Device Expiration Date | 1995-11-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HISTORICAL PUERTO RICO |
| Manufacturer Address | GUIDANT PUERTO RICO B. V. DORADO PR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1857 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2013-01-11 |