FDA Adverse Event
Other
Summary report: N
INTERSTIM
MDR report key: 741442
·
Received July 12, 2006
Report
- Report Number
- 3004209178-2006-01119
- Event Type
- Other
- Date Received
- July 12, 2006
- Date of Event
- May 12, 2006
- Report Date
- June 16, 2006
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO MEDREL
- Product Code
- EZW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TO DATE MEDTRONIC INC. HAS NOT RECEIVED THE DEVICE FOR EVALUATION. FURTHER INFO HAS BEEN REQUESTED FROM THE HCP. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED IF FUTHER INFO IS RECEIVED OR THE DEVICE RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THROUGH THE MFR'S REP THAT THE PT'S INTERSTIM NEUROSTIMULATOR SYSTEM WAS REMOVED DUE TO AN INFECTION. A NEW NEUROSTIMULATOR WAS IMPLANTED. NO FURTHER INFO HAS BEEN MADE AVAILABLE FROM THE HCP AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | IPG | EZW | MDT PUERTO RICO OPERATIONS CO MEDREL | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | LEAD MODEL 3889 LOT# J0555397V IMPLANTED| EXPLANTED |