FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2890847
·
Received December 31, 2012
Report
- Report Number
- 3004209178-2012-12387
- Event Type
- Malfunction
- Date Received
- December 31, 2012
- Report Date
- December 8, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3886, LOT# L90839, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: LEAD: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT ADMITTED HIMSELF TO A CLINIC WHERE HE WAS EXPERIENCING SHOCKING OR JOLTING IN THE RECTUM. THIS STARTED TO OCCUR EARLIER THAT DAY WITH NO TRAUMA REPORTED. THE REPORTER INDICATED THAT THE PATIENT TURNED STIMULATION OFF BUT WAS STILL EXPERIENCING THE SHOCKING. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS VERIFIED TO BE OFF AND AT 0V. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |