FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1061797
·
Received June 13, 2008
Report
- Report Number
- 3004209178-2008-03242
- Event Type
- Injury
- Date Received
- June 13, 2008
- Report Date
- May 14, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BUZZING IN HEAR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S INTERSTIM DEVICE WAS ONLY EFFECTIVE FOR HER URINARY RETENTION FOR A COUPLE OF MONTHS FOLLOWING IMPLANT. SHE HAS NOT YET RECEIVED REPROGRAMMING AND SHE NOW EXPERIENCES PAINFUL URINARY TRACT INFECTIONS TWICE A MONTH AND REQUIRES NEAR CONSTANT ANTIBIOTIC TREATMENT. CONCERN WAS EXPRESSED OVER THE DEVICE CAUSING NERVE DAMAGE BECAUSE THE PATIENT'S FOOT TWITCHES AND SHE EXPERIENCES BUZZING IN HER EAR WHEN ON THE PHONE. FURTHER INFORMATION IS BEING REQUESTED FORM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| LEAD: MODEL 3093| EXPLANTED: |