FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3020076
·
Received March 25, 2013
Report
- Report Number
- 3004209178-2013-04213
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 7, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE ANALYSIS WAS NOT COMPLETE AT THE TIME OF SUBMISSION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 3058 (LOT # NJY207373H ) SHOWED INS CONNECTOR MODULE CONNECTOR BLOCK(S) OUT OF ALIGNMENT.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE SET SCREW IN THE DEVICE WOULD NOT TIGHTEN DOWN AND CONNECT TO THE LEAD. A DIFFERENT DEVICE WAS USED AND THE PATIENT'S STATUS WAS REPORTED AS ALIVE AND WITHOUT INJURY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122599 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |