MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)

Event Date 11/21/2008

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 3093-28, lot# v174650, implanted: (b)(6) 2008, product type lead.

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for interstim other.It was reported their ins was explanted about 2 years after it was put in, the patient did not know the explant date.The patient stated therapy never helped her symptoms.The patient stated that shortly after it was implanted they started having so much pain in the area where the ins was, she could not even lay in bed.The patient noted every time she rolled over she was in pain.The patient was sleeping in a chair.The patient noted she did that for 2 years and told the healthcare professional (hcp) to take it out.Additional information from patient on (b)(6) reported the device was explanted after she was implanted because she experienced so much trouble with the device.The patient noted the device was removed partially, with the tubes still inside her.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that the patient had their device taken out many years ago and thought it must have been in 2010.It was noted that the reason they had it removed was that it stuck out and they couldn¿t sleep in bed and couldn¿t put up with it.The doctor left the wires in because they were embedded in there.No further complications were reported/anticipated.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6958963
• MDR Text Key: 89633688
• Report Number: 3004209178-2017-22065
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

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: 04/14/2010
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 12/07/2017
• Date Device Manufactured: 10/23/2008
• 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: 78 YR