FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1854223
·
Received September 30, 2010
Report
- Report Number
- 3004209178-2010-07476
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 2, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN COULD NOT INSERT HE LEAD INTO THE DEVICE ON BOTH IMPLANTABLE PULSE GENERATORS. THE PHYSICIAN SAID IT FELT LIKE THE SCREW WAS STRIPPED AND IT WOULD NOT LOOSEN OR TIGHTEN TO ALLOW THE LEAD TO BE INSERTED. A NEW DEVICE WAS USED AND THE PATIENT RECOVERED WITHOUT SEQUELAE. FOR INFORMATION ON ADDITIONAL RELATED DEVICES, SEE MANUFACTURE REPORT #3004209178-2010-07474.
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 | EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 3058| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL WRENCH, LOT# UNK| IMPLANTED:| ACCESSORY: MODEL WRENCH, LOT# UNK| EXPLANTED:| LOT# NJY152206H |