FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2182287
·
Received July 11, 2011
Report
- Report Number
- 3004209178-2011-05274
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 16, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS IN A POWER ON RESET CONDITION AFTER CARDIOVERSION. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT #NAH039563V| IMPLANTED:| LEAD: MODEL 3889, LOT #J0454724V| PROGRAMMER: MODEL 3037, LOT #NJD068101N| EXPLANTED: |