FDA Adverse Event Injury Summary report: N

ACTIVA

MDR report key: 5896784 · Received August 23, 2016

Report

Report Number: 3004209178-2016-17454
Event Type: Injury
Date Received: August 23, 2016
Report Date: August 23, 2016
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF THE INS, MODEL 37601, SERIAL NO. (B)(4), FOUND THE INS BATTERY NORMAL END OF LIFE, TELEMETRY AND OUTPUT OKAY WITH NO SIGNIFICANT ANOMALIES.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURING REPRESENTATIVE THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) DEPLETED IN LESS THAN TWO YEARS. THE MANUFACTURING REPRESENTATIVE THOUGHT MAYBE THE PARAMETERS AND IMPEDANCES MAY HAVE CONTRIBUTED TO THE DEPLETION. THE INS HAD REACHED END OF SERVICE. A REVISION WAS DONE AND THE INS EXPLANTED AND REPLACED. THE PATIENT WAS ALIVE WITH NO INJURY. THE PATIENT'S INDICATION FOR USE IS PARKINSON'S DISEASE. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT CONTACTS 1, 2, 3 ON THE RIGHT LEAD HAD IMPEDANCES HIGHER THAN 40,000 OHMS. CONTACTS ON THE LEFT LEAD HAD NORMAL IMPEDANCES IN THE RANGE OF 793-1255 OHMS. THE RIGHT LEAD CONFIRMATION WAS CONTACT 1-C+, 4.5V, 90 US, AND 170 HZ. THE LEFT LEAD CONFIRMATION WAS 7-,C+, 3.1 V, 120 US, AND 170 HZ.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
547818	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC PUERTO RICO OPERATIONS CO.	37601

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention