UNKNOWN IMPLANTABLE NEUROSTIMULATOR

MDR report key: 2893641 · Received January 2, 2013

Report

Report Number: 3007566237-2013-00011
Event Type: Malfunction
Date Received: January 2, 2013
Report Date: December 11, 2012
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: MHY
PMA / PMN Number: P960009
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

ANALYSIS OF THE LEAD RESULTED IN NO ANOMALIES FOUND ANALYSIS OF THE STYLET ACCESSORY RESULTED IN NO ANOMALIES FOUND.

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL DEVICE: PRODUCT ID: 3389S-40, LOT#: VA0477H, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING INTRAOPERATIVE TESTING, ELECTRODE 1 REQUIRED HIGHER AMPLITUDES THAN THE OTHER ELECTRODES (0, 2, AND 3) TO ACHIEVE THERAPEUTIC EFFECT. THE REPORTER STATED THAT IMPEDANCES WERE CHECKED, AND ELECTRODES 0, 2, AND 3 HAD MEASUREMENTS AROUND 1800-1900 OHMS. ELECTRODE 1 HAD A MEASUREMENT OF 3800-3900 OHMS WHEN TESTED AT 3.0 VOLTS. IT WAS NOTED THAT THIS WAS WITHIN NORMAL RANGE. IT WAS REPORTED THAT THE NEUROLOGIST AND NEUROSURGEON DECIDED TO EXCHANGE LEADS. THERE WAS NO PATIENT INJURY. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
161	UNKNOWN IMPLANTABLE NEUROSTIMULATOR	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC NEUROMODULATION	NEU_INS_STIMULATOR

Patients

Seq	Age	Sex	Outcome	Treatment
1	00059 YR