FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1112843
·
Received August 13, 2008
Report
- Report Number
- 3004209178-2008-04933
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 15, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A FALL OR SOME OTHER FORM OF TRAUMA AND SUBSEQUENTLY EXPERIENCED SWEATING, A WARM FEELING AT THE DEVICE POCKET, ACUTE PAIN, AND SWELLING AT THE AREA OF PARESTHESIA AND DOWN THE GROIN AND LEG AREA. THESE SYMPTOMS OCCURRED MAINLY AT NIGHT TIME. THE PT WAS ALSO FEELING SHOCKING SENSATIONS AND HAD LOST WEIGHT. HE IS CURRENTLY WORKING WITH HIS PHYSICIAN TO RESOLVE THE ISSUE. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXTENSION MODEL 3095 LOT# NAH017542V| EXPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 3093 LOT# V000591| IMPLANTED |