FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1180907
·
Received September 23, 2008
Report
- Report Number
- 3004209178-2008-06053
- Event Type
- Malfunction
- Date Received
- September 23, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 25, 2008
- Manufacturer
- MPROC, JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A NEW IMPLANT ELECTRODE'S 0 AND 1 HAD AN IMPEDANCE OF LESS THAN 50. ALL THE OTHER IMPEDANCES WERE FINE. THE PT HAD GOOD RESPONSE WITH ELECTRODE'S 0- AND 3+. IT WAS NOTED THE PHYSICIAN HAD DIFFICULTY INSERTING THE LEAD - MET RESISTANCE. THE PHYSICIAN TOOK THE LEAD OUT, REINSERTED IT, RESISTANCE STILL MET. THE PT WAS CLOSED UP AND PROGRAMMED AROUND IT. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MPROC, JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | EXPLANTED:| LEAD: MODEL 3093 |