FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2010572
·
Received March 1, 2011
Report
- Report Number
- 3004209178-2011-01516
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- December 1, 2010
- Report Date
- January 18, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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). REASON FOR LATE MDR DUE TO MANUFACTURER EMPLOYEE. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S DEVICE WAS REPLACED DUE TO AN OVERDISCHARGE. ON (B)(6) 2010, IT WAS REPORTED THE PATIENT'S DEVICE WAS OVERDISCHARGED. ON (B)(6) 2011, THE PATIENT'S DEVICE WAS REPLACED. DURING REPLACEMENT, IT WAS DISCOVERED THAT, BECAUSE THE PLACEMENT OF THE DEVICE AND THE PATIENT'S BODY TYPE, RECHARGING WOULD HAVE BEEN "NEAR IMPOSSIBLE." THE PATIENT RECOVERED FROM THE REPLACEMENT SURGERY WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | EXPLANTED:| EXPLANTED:| ADAPTER: MODEL 74002, LOT# N233270| PROGRAMMER: MODEL 37743, LOT# NKE142329N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3890, LOT# V003686| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA122743N| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU106740V| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU104653V| LEAD: MODEL 3890, LOT# V004036| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED: |