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

Model Number 37612

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pocket Erosion (2013); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that on 2014 (b)(6), the patient felt their ability to empty waxed and waned.On 2014 (b)(6), the patient had noticed more straining to void and decreased electrophysiological sensations.The health care provider (hcp) stressed that they did not have to feel anything specific as long as they were emptying well.The patient¿s post-void residual (pvr) had risen to between 120 and 160ccs and they were reprogrammed on 2014 (b)(6).Three days later, the patient¿s pvr was less than 100ccs and they were happy with this.The patient had a cystoscopy and endoscopy on 2014 (b)(6).The bladder was examined thoroughly and revealed some mild focal cystitis.Later the patient had an eroding sacral root pulse generator.The patient had run the gamut of more conservative therapy and ultimately it was elected to go ahead with explant on 2014 (b)(6).The area of erosion was visualized and an incision was made over the old implantable neurostimulator (ins) wound.The ins was disconnected in the appropriate fashion, as per the manufacturer.The wound was copiously irrigated with antibiotic solution and packed.The entire procedure was completed without complications.A new ins was implanted on 2014 (b)(6).No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Product id 37651, serial# (b)(4); product type recharger product id 37642, serial# (b)(4); product type programmer, patient product id 3093-33, lot# va09r0z, implanted: 2013 (b)(6); product type lead product id 3708320, serial# (b)(4), implanted: 2013 (b)(6), explanted: 2014 (b)(6); product type extension id 3093-33, lot# va091q9, implanted: 2013 (b)(6); product type lead.(b)(4).Device was used for an off label indication.The indication the device was used for was urinary control.

• 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: 4765630
• MDR Text Key: 5796138
• Report Number: 3004209178-2015-08948
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Date Device Manufactured: 05/09/2013
• 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