MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-11 for UNKNOWN 439-07 manufactured by Guidant Angleton/st. Paul.
[3216540]
Boston scientific received information that this chronic lead has exhibited an increased pacing impedance and it is now great than 2100 ohms. Boston scientific technical services (ts) was consulted and suggested the lead may be failing as there are numerous reports in the past speaking to increased impedances, however, the patient refuses to get any further treatment. The lead remains implanted. To date, no adverse patient effects have been reported.
Patient Sequence No: 1, Text Type: D, B5
[10422667]
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 | 2124215-2012-16614 |
| MDR Report Key | 2911745 |
| Report Source | 07 |
| Date Received | 2013-01-11 |
| Date of Report | 2012-12-07 |
| Date of Event | 2012-12-07 |
| Date Mfgr Received | 2012-12-07 |
| 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 | GUIDANT ANGLETON/ST. PAUL |
| Manufacturer Street | INTERMEDICS |
| Manufacturer City | ANGLETON TX |
| 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 | 2013-01-11 |
| Model Number | 439-07 |
| ID Number | MYOCARDIAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUIDANT ANGLETON/ST. PAUL |
| Manufacturer Address | INTERMEDICS ANGLETON TX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 439 | 2013-01-11 |