FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1812542
·
Received August 16, 2010
Report
- Report Number
- 3004209178-2010-06130
- Event Type
- Injury
- Date Received
- August 16, 2010
- Date of Event
- May 16, 2010
- Report Date
- July 16, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT PT FELT NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT FOLLOWING A BAD FALL ON (B)(6). SHE STOPPED FEELING THE STIMULATION SENSATION TWO DAYS AFTER THE FALL AND HER URINARY ISSUES RETURNED.
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 | 57 YR | Other | PROGRAMMER: MODEL 3037, LOT# NJD093072N| IMPLANTED:| LEAD: MODEL 3889, LOT# V339124 |