MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Delayed Charge Time (2586); Communication or Transmission Problem (2896)

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

Event Date 11/14/2014

Event Type  Injury  

Event Description

It was reported the dystonia patient¿s implantable neurostimulator (ins) and recharger ¿hardly and slowly worked together telemetrically during charging.¿ it was further reported the patient ¿needed a long time to recharge on a daily basis.¿ during the charging process, the recharger reportedly had two coupling bars at most.It was noted that ¿all possible ways to improve the coupling¿ between the devices was attempted, but ¿without success.¿ a second recharger was tested with the patient¿s ins with ¿no success/same result.¿ it was noted ¿the recharger did not seem to be faulty¿ as the patient was tested ¿with multiple rechargers and the same issue arose.¿ the patient¿s ins ¿did not seem to be flipped¿ when examined in (b)(6) 2014.Though it was noted an x-ray had not initially been performed, the patient¿s ¿extension could be palpated to exit the ins clock-wise¿ and as a result it was reported ¿it was unlikely flipped.¿ the patient ¿had a good motor benefit¿ at that time.Additional information reported another investigation of the patient that was performed at the time of report concluded that ¿it seemed the device was flipping in the pocket.¿ it was stated the ¿patient had a minor trauma and the suture probably got loose.¿ x-ray examination of the patient found ¿the extensions were twiddled (spiral).¿ it was noted that ¿since the device was sometimes in a normal position previously, they did not manage to find out about the flip.¿ the patient was to undergo ¿a short revision surgery to fix it in the pocket.¿ a supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_ext, serial# unknown, product type: extension.Product id: neu_ unknown_ext, serial# unknown, product type: extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• 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: 4512801
• MDR Text Key: 16539905
• Report Number: 3004209178-2015-02922
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/12/2015
• Date Device Manufactured: 05/22/2014
• 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: 00065 YR
• Patient Weight: 70