MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Burning Sensation (2146); Electric Shock (2554)

Event Date 05/07/2014

Event Type  Injury  

Event Description

It was reported the patient had complained of being shocked in the chest from the device and they had a pain that would run down the left side of their body and down their left leg.It was noted the device was explanted on the day of report.It was stated a different product was used and the issue was resolved.It was noted the patient status at the time of report was alive with no injury.It was noted the patient had a burning sensation at the device pocket at the right side implant.

Manufacturer Narrative

Concomitant medical products: product id 748240, serial# (b)(4), implanted: (b)(6) 2003, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387-40, lot# j0225449v, implanted: (b)(6) 2003, product type: lead; product id 3387-40, lot# j0225449v, implanted: (b)(6) 2003, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Analysis of the implantable neurostimulator (s/n (b)(4)) found no significant anomalies, the ins was functionally okay.Analysis of the extension (s/n (b)(4)) found the extension body outer insulation had breached depression.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 3836594
• MDR Text Key: 4407318
• Report Number: 3004209178-2014-09752
• 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: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2014
• Initial Date FDA Received: 05/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• 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
• Patient Age: 00060 YR