FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2201758
·
Received August 5, 2011
Report
- Report Number
- 3007566237-2011-06096
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- May 6, 2011
- Report Date
- July 25, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FINAL ANALYSIS OF THE PUMP REPORTED HIGH S2 BATTERY RESISTANCE. THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1484 OHMS. PUMP'S LOGS SHOWED AN ERI, MULTIPLE LOW BATTERY RESETS, AND PUMP IN SAFE STATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) 2011, THE REMAINING LONGEVITY OF THE PUMP AS PER ELECTIVE REPLACEMENT INDICATOR (ERI) WAS (B)(6). (B)(6) LATER I.E. (B)(6) 2011, THE REMAINING LONGEVITY WAS (B)(6). THE PUMP WAS REPLACED. THE DRUG DELIVERED WAS LIORESAL 2000 MCG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |