MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-03 for UNKNOWN 439-07 manufactured by Guidant Angleton/st. Paul.
[3799041]
Boston scientific received information that this right ventricular (rv) lead exhibited high out of range pacing impedance measurements. The field representative discussed the issue with boston scientific technical services (ts) as a potiential fracture or lead-pg connection issue. Ts recommended x-ray and isometrics and pocket manipulation to help evaluate. The field representative indicated that since the patient does not use that lead, the physician chose to keep it in place for now. There were no adverse patient effects reported.
Patient Sequence No: 1, Text Type: D, B5
[11267286]
All available information indicates that this product remains in service. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2013-13256 |
| MDR Report Key | 3384825 |
| Report Source | 07 |
| Date Received | 2013-10-03 |
| Date of Report | 2013-07-23 |
| Date of Event | 2013-07-23 |
| Date Mfgr Received | 2013-07-23 |
| Date Added to Maude | 2013-10-03 |
| 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 | 2013-10-03 |
| Model Number | 439-07 |
| ID Number | MYOCARDIAL |
| Operator | LAY USER/PATIENT |
| 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 | 2013-10-03 |