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

Model Number NEU_ENS_STIMULATOR

Device Problems Break (1069); Low impedance (2285); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

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

Event Type  Injury  

Event Description

A health care provider (hcp) reported via a manufacturing representative that impedances were measured to be low for all electrodes.A single impedance values for all monopolar configurations and a single impedance value for all bipolar configurations led the hcp to the conclusion that the electrodes were short circuited.The hcp claimed the stimloc clamp squeezed the clamp too much, when the hcp tried to withdraw the stylet from the lead, the hcp had over tightened the screw of the ¿white plastic part¿ that holds the lead on the microdrive.When the hcp pulled the stylet, they broke the white plastic electrode cover where the stylet was fixed, stressing and damaging the lead just below the connector.All of the implanted components were tested from the implantable neurostimulator (ins) to the lead to identify the location of the short circuit.The lead was identified as the damaged part.The lead was not able to be replaced during the initial surgery so a revision was scheduled five days later using the previous planning and ct scans.After the lead replacement, the issue was resolved.

Manufacturer Narrative

Concomitant product: product id 3389s-40, lot # va0tf9y, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id neu_unknown, serial # unknown, product type unknown.(b)(4).

• Brand Name: EXTERNAL NEUROSTIMULATOR, UNKNOWN
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4973843
• MDR Text Key: 6355796
• Report Number: 3007566237-2015-02198
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2015
• 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
• Patient Age: 00053 YR