MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37602

Device Problems Pocket Stimulation (1463); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171)

Event Type  Injury  

Event Description

It was reported that the patient¿s setscrew was not tightened up enough.The patient had to be brought back in and re-tightened.Three to four days later the patient experienced tingling sensations in the pocket area.The patient was brought back in again and ¿that was all corrected.¿ the patient recovered without sequela.

Event Description

Additional information received reported that the surgical procedure to re-open the patient found the 0 and 3 setscrew not secured.They were re-tightened and there were no further complaints from the patient.

Manufacturer Narrative

Product id 37642, serial# (b)(4), product type programmer, patient product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3389s-40, lot# v409757, implanted: 2010 (b)(6); product type lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3701368
• MDR Text Key: 4229020
• Report Number: 3004209178-2014-05080
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2014
• Date Device Manufactured: 11/20/2013
• 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