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 PATCH 0040 manufactured by Historical Cpi St. Paul.
[3119907]
Boston scientific received information that during a device change-out procedure to a competitor's device, these epicardial patches were evaluated with a pacing system analyzer (psa). The impedance results were > 2000 ohm on one patch and the other measured < 200 ohms. The field representative did not know which patch had which result as he was not directly involved in the case. A shock was then delivered through the new device, done in the patch to patch or cold can configuration, and the measured impedance value was >200 ohms. Boston scientific technical services (ts) discussed with the field representative that having a reading of > 2000 ohms, and then a shock lead impedance of > 200 ohms, were out of range, and potential causes were discussed. Additional information was received that the patches were surgically abandoned and a new transvenous lead was implanted. There were no adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
[10389503]
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 | 2124215-2013-00017 |
| MDR Report Key | 2911899 |
| Report Source | 07 |
| Date Received | 2013-01-11 |
| Date of Report | 2012-11-30 |
| Date of Event | 2012-11-30 |
| Date Mfgr Received | 2012-11-30 |
| 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 | HISTORICAL CPI ST. PAUL |
| Manufacturer Street | GUIDANT CORPORATION |
| Manufacturer City | SAINT PAUL MN |
| 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 | 2013-01-11 |
| Model Number | 0040 |
| ID Number | A 67 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HISTORICAL CPI ST. PAUL |
| Manufacturer Address | GUIDANT CORPORATION SAINT PAUL MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1600 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2013-01-11 |