FDA Adverse Event
Malfunction
Summary report: N
SYNERGY COMPACT PLUS
MDR report key: 2241039
·
Received August 17, 2011
Report
- Report Number
- 3004209178-2011-06473
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Report Date
- July 26, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IMPEDANCES >4,000 OHMS WERE REPORTED ON SOME BIPOLAR PAIRS. THE BATTERY VOLTAGE WAS NOTED TO BE AT 2.52V. AN UNK MEDICAL OR THERAPY ISSUE WAS REPORTED, HOWEVER, DETAILS WERE NOT PROVIDED. A POWER ON RESET (POR) CONDITION OCCURRED AFTER THE PT HAD THE NEUROSTIMULATOR TURNED OFF FOR ABOUT 16 MONTHS DURING PREGNANCY. IT WAS NOTED THAT THE PT HAD A COLECTOMY PERFORMED IN (B)(6) 2011. THE PT ATTEMPTED TO TURN THE NEUROSTIMULATOR ON PRIOR TO THAT TIME, BUT IT WOULD NOT TURN ON. THE POR WAS CLEARED WITH A CLINICIAN PROGRAMMER. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY COMPACT PLUS | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7479B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LEAD: MODEL 3093, LOT# V000225| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU087021V| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU092469V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V000225| PROGRAMMER: MODEL 7439, LOT# NJD014940N| EXPLANTED:| IMPLANTED: |