FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1993864
·
Received February 11, 2011
Report
- Report Number
- 3004209178-2011-01062
- Event Type
- Injury
- Date Received
- February 11, 2011
- Date of Event
- January 1, 2010
- Report Date
- January 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THERE WAS NO ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. IMPLANTABLE NEUROSTIMULATOR INTERROGATION REVEALED HIGH, OUT-OF-RANGE IMPEDANCES FOR ALL ELECTRODE COMBINATIONS EXCEPT 2-3. THE PT WAS TAKEN TO THE OPERATING ROOM. DURING SURGERY, THE HCP DISCOVERED THAT THE LEAD BODY WAS DAMAGED. INDIVIDUAL LEAD WIRES WERE EXPOSED. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | LEAD: MODEL 3998, LOT# J0455331V| ACCESSORY: MODEL 37752, LOT# NKA036221N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE156170N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082 LOT# NKB007275N |