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 PATCH 0041 manufactured by Historical Puerto Rico.
[3064719]
Boston scientific received information from a competitive field representative that an out of range shock impedance measurement of 168 ohms was observed on their device. Discussed with boston scientific technical services (ts) that the physician may want to consider additional testing to determine the integrity of the lead. There were no adverse patient effects reported. The local field representative was contacted, however, no additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[10456390]
To this date this lead remians implanted with no change. 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 | 2124215-2012-14343 |
| MDR Report Key | 2906783 |
| Report Source | 07 |
| Date Received | 2013-01-10 |
| Date of Report | 2012-10-09 |
| Date of Event | 2012-10-09 |
| Date Mfgr Received | 2012-10-09 |
| 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 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 | 2013-01-10 |
| Model Number | 0041 |
| ID Number | L 67 |
| Device Expiration Date | 1996-11-23 |
| 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 | 1786 | 2013-01-10 |