FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2322630
·
Received October 13, 2011
Report
- Report Number
- 3004209178-2011-08895
- Event Type
- Malfunction
- Date Received
- October 13, 2011
- Date of Event
- April 11, 2011
- Report Date
- October 12, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FINAL ANALYSIS OF THE PUMP REVEALED BATTERY RESISTANCE HIGH. PER ANALYSIS, "IN HOUSE BATTERY TESTER PAR 273A REPORTS R = 342 OHMS. = (-3.03V - -1.32V) / (0.00002A - 0.00502A) OCV = 3.065". PER ANALYSIS, THE PUMP CONTAINED BACLOFEN.
Description of Event or Problem · 1
THE DEVICE WAS REPLACED PROPHYLACTICALLY TO AVOID IN-VIVO BATTERY DEPLETION. THE DEVICE WAS RETURNED FOR DISPOSAL. NO PT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N081218011 |