FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2191028
·
Received July 19, 2011
Report
- Report Number
- 3004209178-2011-05589
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 24, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PT HAD "GOOD" RELIEF FOR THE (B)(6) AFTER IMPLANT, BUT THEN LOST RELIEF (B)(6). THERE WAS NO STIMULATION SENSATION. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
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 | 86 YR | LEAD: MODEL 3093, LOT# V706821| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD130877N |