RESTORE ADVANCED
Report
- Report Number
- 3004209178-2012-06193
- Event Type
- Injury
- Date Received
- July 30, 2012
- Report Date
- June 28, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS, MODEL #: 37713, SERIAL #: (B)(4)) FOUND NO ANOMALY. BURN MARKS FROM SUSPECTED CAUTERY WERE NOTED ON THE EXTERNAL PART OF THE INS. GOOD, STABLE OUTPUT WAS MEASURED ON ALL ELECTRODE PAIRS THE INS HAD WHEN RECEIVED. ANALYSIS OF THE EXTENSION (MODEL #: 3708240, SERIAL #: (B)(4)) FOUND THE PROXIMAL END OF THE CONNECTOR NOT COMPLETELY SEATED IN THE INS CONNECTOR PORT. IT WAS NOTED THAT A SETSCREW MARK WAS TOO PROXIMAL, AS IT WAS BETWEEN THE #0 AND #1 CONTACTS. IT WAS ALSO NOTED THAT THERE WAS A BREACHED CUT IN THE INSULATION ON THE CIRCUIT #4-7 LEG OF THE EXTENSION. NO SHORTS BETWEEN CIRCUITS WERE DETECTED. THE #3 CIRCUIT WAS INTERMITTENT ON THE LEAD CONNECTED TO THE #4-7 CIRCUITS OF THE EXTENSION. THE #2 CIRCUIT WAS OPEN ON THE LEAD CONNECTED TO THE #0-3 CIRCUITS OF THE EXTENSION. IT WAS NOTED THAT THERE WAS ONLY OUTPUT ON ELECTRODE PAIRS USING THE #0, #1, AND #2 CIRCUITS OF THE LEAD CONNECTED TO THE #4-6 CIRCUITS OF THE EXTENSION AND THE #11-13 CIRCUITS OF THE INS BECAUSE IT WAS NOT COMPLETELY SEATED IN THE #8-15 PORT OF THE INS. ANALYSIS OF THE FIRST LEAD (MODEL #: 3487A-45, LOT #: V060158) FOUND THE #2 CONDUCTOR BROKEN IN THE BODY OF THE LEAD, 12.8 CENTIMETERS FROM THE DISTAL END. NO SHORTS BETWEEN CIRCUITS WERE DETECTED. THE #2 CIRCUIT OF THE LEAD WAS OPEN. THE OUTER INSULATION WAS MELTED, AND INDICATED SUSPECT CAUTERY. ANALYSIS OF THE SECOND LEAD (MODEL #: 3487A-45, LOT #: V066757) FOUND NO SIGNIFICANT ANOMALY. THE #3 WELD WAS BROKEN ON THE #3 ELECTRODE DUE TO OVERSTRESS. IT WAS NOTED THAT THERE WERE MULTIPLE BREACHED AND COSMETIC MELTED SPOTS IN THE OUTER INSULATION. THE DISTAL END OF THE LEAD WAS SEVERELY STRETCHED AT THE #1, #2, AND #3 ELECTRODES. NO SHORTS BETWEEN CIRCUITS WERE DETECTED. THE #3 CIRCUIT WAS INTERMITTENT. ANALYSIS OF THE THIRD LEAD (MODEL # 3778-75, LOT #: V071016009) FOUND NO SIGNIFICANT ANOMALY. THE OUTER INSULATION WAS COSMETICALLY MELTED IN SEVERAL SPOTS, INDICATIVE OF SUSPECT CAUTERY. THE OUTER INSULATION WAS PINCHED 15.2 CENTIMETERS FROM THE DISTAL END. NO SHORTS BETWEEN CIRCUITS WERE DETECTED. ANALYSIS OF THE FIRST ANCHOR (MODEL #: UNKNOWN, SERIAL/LOT #: UNKNOWN) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE ANCHOR WAS CUT TO LENGTH AT IMPLANT. ANALYSIS OF THE SECOND ANCHOR (MODEL #: UNKNOWN, SERIAL/LOT #: UNKNOWN) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE ANCHOR WAS CUT TO LENGTH AT IMPLANT.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
(B)(4): PRODUCT TYPE ACCESSORY, PRODUCT ID 3778-75, LOT# V071016009, PRODUCT TYPE LEAD, PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3487A-45, LOT# V060158, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3487A-45, LOT# V066757, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED BECAUSE IT WAS NO LONGER PROVIDING THE PATIENT WITH THERAPEUTIC EFFECT. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 YR | Required Intervention |