MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-22 for PATCH 0067 manufactured by Cpi - Del Caribe.
[18845194]
Boston scientific received information that this right ventricular (rv) lead exhibited a high out of range shock impedance measurement. The daily measurements show impedance at 60-80 ohms. Boston scientific technical services (ts) suggested troubleshooting options. A non-invasive programmed stimulation (nips) test was scheduled. There were no adverse patient effects reported.
Patient Sequence No: 1, Text Type: D, B5
[19290452]
All available information indicates the device remains in service. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2013-01617 |
| MDR Report Key | 2924952 |
| Report Source | 07 |
| Date Received | 2013-01-22 |
| Date of Report | 2012-11-21 |
| Date of Event | 2012-11-21 |
| Date Mfgr Received | 2012-11-21 |
| Device Manufacturer Date | 2007-10-12 |
| Date Added to Maude | 2013-01-22 |
| 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 | 2013-01-22 |
| Model Number | 0067 |
| ID Number | EPI-PATCH SMALL |
| Device Expiration Date | 2009-10-12 |
| 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 | 0 | 2013-01-22 |