NEU_INS_STIMULATOR

Report

Report Number: 3004209178-2012-10691
Event Type: Injury
Date Received: November 21, 2012
Date of Event: October 26, 2012
Report Date: October 26, 2012
Manufacturer: MEDTRONIC NEUROMODULATION SULLIVAN LAKE
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4): FINAL ANALYSIS OF THE EXTENSION FOUND THAT THE CONNECTOR #0 WAS TWISTED IN THE MOLDED RUBBER IN BOTH DIRECTIONS WHILE TIGHTENING AND LOOSENING THE SETSCREW. THE #0, 2 AND 3 SETSCREWS WERE MISSING.

Additional Manufacturer Narrative · 1

PRODUCT ID 3550-05, LOT# UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

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 DEFORMATION OF THE CONNECTOR ON THE EXTENSION WAS SUSPECTED. THE PATIENT WAS IMPLANTED WITH A TEST STIMULATION SYSTEM ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD A PROCEDURE TO REMOVE THE TEST STIMULATOR AND CONNECT WITH THE IMPLANTABLE STIMULATOR. THE PHYSICIAN EXPERIENCED RESISTANCE IN THE CONNECTOR ON THE ADAPTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Description of Event or Problem · 1

IT WAS NOTED THAT THERE WAS NO HEALTH HAZARD TO THE PATIENT AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEU_INS_STIMULATOR	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC NEUROMODULATION SULLIVAN LAKE	NEU_ENS_STIMULATOR

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention