MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-05 for PATCH 0068 manufactured by Cpi - Del Caribe.
[2600511]
Boston scientific received information that this patch lead displayed high out of range shock impedance measurements. A chest x-ray will be performed in the near future to see if there is a visible lead or setscrew issue. The patient is currently programmed to monitor only (mo), and will remain in the hospital until this issue is resolved. A save to disk was reviewed by technical services (ts). Ts confirmed there were high oor shock impedance measurements. There was no noise observed on the electrogram, and the rv pacing impedance was stable and within range. Ts provided troubleshooting methods to help find the cause for oor shock impedance measurements. Troubleshooting methods were attempted. Noise was not observed when the pocket was manipulated. Several shock impedance tests were performed, including 1:1 joule commanded shocks, which again revealed oor shock impedance measurements. A chest x-ray was performed, but no anomalies noted. Ts discussed that the best explanation for the oor measurements is a conductor or mesh fracture, or loose set screw somewhere on the patch electrode connected to the distal coil port of the pg. Ts suggested a high resolution x-ray be performed, and to check that the rv and left ventricular (lv) patches are connected properly. The physician stated that this patient will be followed-up in the near future. There were no adverse patient effects reported. Subsequently, a follow-up procedure was performed. An open measurement on the system was performed, and it was observed there was an issue with this 0068 distal patch lead. The decision was made to implant a competitor sq lead. Once connected to the associated 0067 patch lead and icd, all measurements were normal and within range.
Patient Sequence No: 1, Text Type: D, B5
[9951425]
This patch lead was surgically abandoned. At this time there is no additional information. Should additional information become available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2012-01701 |
| MDR Report Key | 2519091 |
| Report Source | 05 |
| Date Received | 2012-04-05 |
| Date of Report | 2012-01-09 |
| Date of Event | 2012-01-09 |
| Date Mfgr Received | 2012-01-09 |
| Device Manufacturer Date | 2003-10-22 |
| Date Added to Maude | 2012-04-05 |
| 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 | CPI - DEL CARIBE |
| 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 | 2012-04-05 |
| Model Number | 0068 |
| ID Number | EPI-PATCH LARGE |
| Device Expiration Date | 2005-10-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CPI - DEL CARIBE |
| Manufacturer Address | GUIDANT PUERTO RICO B. V. DORADO PR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 67 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2012-04-05 |