FDA Adverse Event Malfunction Summary report: N

PRIMEADVANCED

MDR report key: 2955646 · Received February 11, 2013

Report

Report Number: 3004209178-2013-02528
Event Type: Malfunction
Date Received: February 11, 2013
Report Date: January 23, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
PMA / PMN Number: P840001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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

(B)(4).

Additional Manufacturer Narrative · 1

(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

ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT AS FAR AS THE REPORTER KNEW, "ALL WAS WELL" WITH THE PATIENT FOLLOWING REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH HIGH IMPEDANCES. IT WAS LATER REPORTED THERE WAS NO PATIENT INJURY.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING NORMAL IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY REPLACEMENT THERE WERE IMPEDANCES GREATER THAN 40000 OHMS ON ALL CONTACTS EXCEPT CONTACT 8. THE REPORTER STATED THAT THE DOCTOR REMOVED THE LEADS, CLEANED THEM OFF, AND SUCTIONED THE PORT. A SNAP-LID TEST CABLE WAS USED TO TEST THE LEADS. IT WAS REPORTED THAT THE LEADS CHECKED OK AND A NEW INS WOULD BE TRIED. TWELVE DAYS LATER, IT WAS REPORTED THAT THE INS WAS FOUND TO BE THE SOURCE OF THE IMPEDANCE PROBLEMS, AND THE INS WAS REPLACED WITH A NEW INS. IT WAS NOTED THAT THE INS WITH HIGH IMPEDANCES WAS NEVER IMPLANTED IN THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
58451	PRIMEADVANCED	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37702

Patients

Seq	Age	Sex	Outcome	Treatment
1