FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2061919
·
Received April 5, 2011
Report
- Report Number
- 3004209178-2011-02626
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 29, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD SHOCKING/JOLTING SENSATIONS AFTER GOING THROUGH A METAL DETECTOR ABOUT "2 MONTHS AGO". WITHIN THE PAST 3 DAYS OF THE REPORT, THE PATIENT HAD 5-7 HARD SHOCKS THAT FELT LIKE A HEART ATTACK TO THE PATIENT. THE PATIENT WAS UNABLE TO NEITHER TURN OFF THE DEVICE NOR LESSEN THE SHOCKING. THE PATIENT SOUGHT CARE AT THE EMERGENCY ROOM TWICE AND WAS UNABLE TO BE HELPED. IT WAS FURTHER REPORTED THAT THE SHOCKING DID STOP ON ITS OWN. THE PATIENT WAS RE-DIRECTED BACK TO THEIR PHYSICIAN. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD117202N| EXPLANTED:| LEAD: MODEL 3093, LOT# V572182 |