FDA Adverse Event
Injury
Summary report: N
RESTORE SENSOR
MDR report key: 2201752
·
Received August 5, 2011
Report
- Report Number
- 3004209178-2011-06103
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 12, 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
ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 37714 SERIAL # (B)(4) DETERMINED THERE WAS NO ANOMALY FOUND WITH THE INS. GOOD, STABLE OUTPUT WAS FOUND ON EACH ELECTRODE PAIR. THE IMPEDANCE TEST IN SALINE RESULT WAS NORMAL IMPEDANCES WERE OBSERVED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. WHEN MEASURING CHANNELS 0 AND 7, IMPEDANCES WERE 0.70 V 20,000 OHMS. FINALLY, THE ELECTRODE AND THE EXTENSION WERE CHANGED BUT THE PROBLEM REMAINED. THE PHYSICIAN DECIDED TO EXPLANT THE STIMULATOR AND THIS RESOLVED THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE SENSOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37714 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |