FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2152312
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04701
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 26, 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 Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THIS OCCURRED INITIALLY AFTER IMPLANT AND THEN SUBSIDED. THE PATIENT THEN FELT THE SHOCKING AT THE INS POCKET SITE. NO FALL OR TRAUMA WAS ASSOCIATED WITH THIS COMPLAINT. THE SENSATION ONLY OCCURRED WHEN THE INS WAS TURNED ON AND PALPITATION DID NOT REPRODUCE THE SHOCKING. IMPEDANCES WERE MEASURED AND RANGED FROM 426 TO 1027 OHMS EXCEPT ON ELECTRODE 01 WHICH WAS < 50 OHMS. AN X-RAY OF THE AREA WAS RECOMMENDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
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 | 72 YR | PROGRAMMER: MODEL 3037, LOT# NJD100258N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V387389 |