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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); High impedance (1291)

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

Event Date 06/05/2015

Event Type  Injury  

Event Description

It was reported that at the implant surgery, impedance measurements were measured at >40,000 ohms on all combinations using electrodes 0 and 1.The connections between the lead, extension, and implantable neurostimulator (ins) were all released and retightened, but impedances were still high.The lead was replaced and all impedances were within normal ranges.Lead breakage was reported.There was no patient injury reported and the patient recovered without sequelae.

Manufacturer Narrative

Concomitant: product id 977a275, lot# 0209493462, implanted: 2015-(b)(6), explanted: 2015-(b)(6), product type lead.Product id 977a275, lot# 0209493462, implanted: 2015-(b)(6), explanted: 2015-(b)(6), product type lead.(b)(4).Analysis of lead model 977a275 lot number 0209493462 found no anomalies.

Manufacturer Narrative

(b)(4).

• 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: 4953857
• MDR Text Key: 6254394
• Report Number: 3007566237-2015-02153
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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