MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-07-06 for PATCH 0041 manufactured by Historical Puerto Rico.
[15509504]
Additional information was received regarding the explant procedure stating that testing with high and low voltage shocks resulted in ruining the existing leads. Therefore, the physician elected to implant a single chamber device.
Patient Sequence No: 1, Text Type: D, B5
[15530179]
.
Patient Sequence No: 1, Text Type: N, H10
[17559074]
Boston scientific received information that this lead was exhibiting impedance measurements less than 200 ohms and no capture despite maximum device outputs. The lead was surgically abandoned during an elective device replacement procedure. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[17749785]
The lead was not returned for testing. Therefore, boston scientific cannot confirm the reported clinical observations. No other adverse events have been reported. This product issue will be updated if additional information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2012-07802 |
| MDR Report Key | 2643544 |
| Report Source | 07 |
| Date Received | 2012-07-06 |
| Date of Report | 2012-06-29 |
| Date of Event | 2012-05-29 |
| Date Mfgr Received | 2012-06-29 |
| Date Added to Maude | 2012-07-06 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2012-07-06 |
| Model Number | 0041 |
| ID Number | L 67 |
| Device Expiration Date | 1996-12-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 0 | 2012-07-06 |