MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A health care provider reported via a manufacturing representative that high impedances were measured during intraoperative testing.The extensions were removed from the implantable neurostimulator (ins), placed in opposite ins channels, and then placed back in their original channels.After moving the extensions around, the impedance issue seemed to be resolved.A week after implant, impedance of contact nine was measured to be above 40,000 ohms.A revision was done and the extensions were disconnected from the ins and switched around.Impedances were then measured to be normal.The extensions were then switched to their original position and impedance was measured to be high on contact nine again.The manufacturing representative had expected contact one to have high impedance following the swap.The extensions were removed again, cleaned and reinserted into the ins.Impedances were then measured to be normal.The issue was resolved at the time of this report.

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), product type: extension.

Event Description

Additional information reported the patient's "therapy was effective" with "no issues seen" as of (b)(6) 2015.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5014521
• MDR Text Key: 23444078
• Report Number: 3007566237-2015-02317
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention