MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-14 for UNKNOWN 4312 manufactured by Guidant Puerto Rico Bv.
[3218306]
Information was received that during the procedure, the suture was not connected to the muscle tissue. The device had moved downward to the lower part of the abdomen. The connections were tight through this and all three adapters had insulation damage where the header ends. It was suspected that the change of device position created too much tension on the adapters. As no device malfunction was suspected and there was sufficient longevity, the device remains implanted with a new rv lead. No adverse patient effects were reported as a result of the procedure.
Patient Sequence No: 1, Text Type: D, B5
[3370406]
Boston scientific received information that the device was programmed to monitor only as there were shock impedance measurements greater than 125 ohms on the right ventricular (rv) lead. A connection issue between the adapter and lead was suspected. As a result, a revision procedure was scheduled. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[10390537]
This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
[10493602]
The product is expected to be returned for analysis. This report will be updated upon return and completion of analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124215-2012-16851 |
| MDR Report Key | 2913199 |
| Report Source | 07 |
| Date Received | 2013-01-14 |
| Date of Report | 2012-12-19 |
| Date of Event | 2012-12-13 |
| Date Mfgr Received | 2012-12-19 |
| Date Added to Maude | 2013-01-14 |
| 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 PUERTO RICO BV |
| 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 | 2013-01-14 |
| Model Number | 4312 |
| ID Number | --- |
| 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 | GUIDANT PUERTO RICO BV |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2013-01-14 |