FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2231113
·
Received August 26, 2011
Report
- Report Number
- 3004209178-2011-06952
- Event Type
- Injury
- Date Received
- August 26, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 16, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A LOSS OF THERAPEUTIC EFFECT OCCURRED. ALSO, THE PT HAD A URINARY TRACT INFECTION AND WAS PLACED ON ANTIBIOTICS FOR THE INFECTION. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention | EXPLANTED: | EXPLANTED: NA| IMPLANTED:| IMPLANTED: | LEAD MODEL 3889 LOT# V750604| LEAD MODEL 3889, LOT # V750604| PROGRAMMER MODEL 3037 LOT# NJD1 35768N |